BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILIFT

    MDR report key: 5081399 · Received September 16, 2015

    Report

    Report Number
    3009481053-2015-00001
    Event Type
    Injury
    Date Received
    September 16, 2015
    Date of Event
    August 13, 2015
    Report Date
    September 16, 2015
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED ONSITE BY REPESENTATIVE.

    Description of Event or Problem · 1

    HANDICARE RECEIVED A REPORT THAT A PATIENT HAD SUSTAINED AN INJURY FROM A FALL WHILE USING A SIT TO STAND DEVICE. THE INITIAL REPORT STATED THAT WHILE THE PATIENT WAS IN A STANDING POSITION, THE LIFTING ARM HAD DIS ATTACHED FROM THE UNIT ALLOWING THE PATIENT TO FALL TO THE GROUND. THE PATIENT HAD SUSTAINED FRACTURES TO THE SHOULDER AREA. AN ACCIDENT/INCIDENT FORM WAS SENT TO THE FACILITY. A HANDICARE REPRESENTATIVE VISITED THE FACILITY IN AN ATTEMPT TO RECREATE THE REPORTED INCIDENT AND INSPECT THE EQUIPMENT. UPON INSPECTION OF THE UNIT, IT WAS ESTABLISHED THAT A RETAINING BOLT WHICH PREVENTS THE LIFT ARM FROM FULLY DISENGAGING FROM THE UNIT WAS MISSING. NO OTHER ISSUES OR SIGNS OF WEAR WERE NOTED. THE REPRESENTATIVE WAS UNABLE TO RECREATE THE INCIDENT WITH STAFF MEMBERS OR OBTAIN A CLEAR DESCRIPTION OF THE EVENT. THE BOLT WAS REPLACED AND THE UNIT WAS PUT BACK INTO SERVICE. THE RETURNED ACCIDENT/INCIDENT REPORT INDICATED THAT THE LIFT TIPPED DURING USE DUE TO THE PATIENT, WHILE IN A STANDING POSITION SHIFTED HIS WEIGHT TO THE LEFT. ATTEMPTS MADE BY HANDICARE TO RECREATE THE EVENT BASED ON THE INFORMATION SUPPLIED WERE UNSUCCESSFUL. BASED ON THE INFORMATION SUPPLIED, HANDICARE BELIEVE THAT THE INCIDENT OCCURRED DUE TO IMPROPER USE OF THE EQUIPMENT AS DESCRIBED IN THE USER MANUAL. HANDICARE HAS RECOMMENDED FURTHER TRAINING AT THE FACILITY ON PROPER USE OF THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614274 MINILIFT SIT TO STAND AID FSA HANDICARE AB 401100334

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization